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Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms - Pneumonia, Aspiration
Conditions: Keywords
LAHNC, Locally Advanced Head and Neck Cancer
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: amoxicillin/clavulanic acid suspension
Type: Drug
Overall Status
Recruiting
Summary
Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life.
The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already
Detailed Description
Concomitant chemoradiotherapy (CRT) is used in locally advanced head and neck cancer (LAHNC). It will be administered to patients for unresectable disease or for organ preservation as primary treatment. Furthermore, it can be used as postoperative treatment in case high risk recurrent disease is present. This treatment induces a high rate of acute toxicity, such as mucositis, dermatitis, dysphagia, anorexia, and pain. Swallowing dysfunction and aspiration are seen in a high proportion (30%-100%) of patients and with an immense impact on Quality of life (QoL).
Around half of the patients will develop an aspiration pneumonia during or shortly after the treatment.
Patients, who develop fever during concomitant chemoradiotherapy, are most of the time admitted in the hospital. In the differential diagnosis pneumonia is on the first place in all those patients. The standard diagnostic procedures consist of a chest X-ray and culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient group.
The treatment of patients treated with chemoradiotherapy who develop fever and have a definite or suspected pneumonia, is administration of antibiotics, most frequently intravenous amoxicillin/clavulanic acid.
LAHNC patients who are smoking and/or with malnutrition are at the highest risk of getting a pneumonia during or after radiotherapy. Because smoking is one of the risk factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD) is frequently present in this group. Also, COPD is a known risk factor for developing pneumonias.
Aspiration is seen in all primary sites of head and neck cancer, sometimes it is seen more frequently in patients with cancer of the larynx and hypopharynx. No data of prophylactic administration of antibiotics are available in LAHNC patients. However, a Cochrane review was published to assess the effects of prophylactic antibiotic regimens for the prevention of respiratory tract infections(RTIs) and overall mortality in adults receiving intensive care.
Around half of the patients will develop an aspiration pneumonia during or shortly after the treatment.
Patients, who develop fever during concomitant chemoradiotherapy, are most of the time admitted in the hospital. In the differential diagnosis pneumonia is on the first place in all those patients. The standard diagnostic procedures consist of a chest X-ray and culture of the sputum and blood. Pneumonia can lead to mortality in this frail patient group.
The treatment of patients treated with chemoradiotherapy who develop fever and have a definite or suspected pneumonia, is administration of antibiotics, most frequently intravenous amoxicillin/clavulanic acid.
LAHNC patients who are smoking and/or with malnutrition are at the highest risk of getting a pneumonia during or after radiotherapy. Because smoking is one of the risk factors of developing head and neck cancer chronic obstructive pulmonary disease (COPD) is frequently present in this group. Also, COPD is a known risk factor for developing pneumonias.
Aspiration is seen in all primary sites of head and neck cancer, sometimes it is seen more frequently in patients with cancer of the larynx and hypopharynx. No data of prophylactic administration of antibiotics are available in LAHNC patients. However, a Cochrane review was published to assess the effects of prophylactic antibiotic regimens for the prevention of respiratory tract infections(RTIs) and overall mortality in adults receiving intensive care.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT.
- Written informed consent
- Expected adequacy of follow-up
Exclusion Criteria:
- Patients with pneumonia within the last 14 days before start of CRT
- Patients with other infections within the last 14 days within the last 14 days before start of CRT
- Patients with use of maintenance antibiotics
- Patients with antibiotic treatment within the last 14 days before start of CRT
- Patients with an allergy on amoxicillin
- Patients with LAHNC which will be treated with CRT as discussed by a multidisciplinary team (i.e. a head and neck surgeon, a medical oncologist, and a radiation oncologist). This can be CRT as primary treatment or postoperative CRT.
- Written informed consent
- Expected adequacy of follow-up
Exclusion Criteria:
- Patients with pneumonia within the last 14 days before start of CRT
- Patients with other infections within the last 14 days within the last 14 days before start of CRT
- Patients with use of maintenance antibiotics
- Patients with antibiotic treatment within the last 14 days before start of CRT
- Patients with an allergy on amoxicillin
Locations
Ziekenhuis Rijnstate
Arnhem, Gelderland, Netherlands
University Medical Center Nijmegen st Radboud
Status: Recruiting
Contact: J. Blaisse, Md - +31 26-3788888 - jblaiss@alysis.nl
Nijmegen, Gelderland, Netherlands
Medisch Centrum Alkmaar
Status: Recruiting
Contact: C. van Herpen, Md - +31 24 361 03 53 - c.vanherpen@onco.umcn.nl
Alkmaar, Netherlands
University Medical Centre Groningen
Status: Not yet recruiting
Contact: C. Smorenburg, Md - +31 72-5484444 - c.h.smorenburg@mca.nl
Groningen, Netherlands
Medisch centrum Leeuwarden
Status: Recruiting
Contact: J. Gietema, Md - +31 50 361 61 61 - j.a.gietema@med.umcg.nl
Leeuwarden, Netherlands
Academical Hospital Maastricht (AZM)
Status: Not yet recruiting
Contact: E. Fiets, Md - +31 58-2866666 - edward.fiets@znb.nl
Maastricht, Netherlands
Status: Not yet recruiting
Contact: - ann.hoeben@mumc.nl
Start Date
December 2011
Completion Date
December 2014
Sponsors
Radboud University
Source
Radboud University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page